35.11 - Biohazard Safety

A. General. The proper management of biological agents and the vectors that may harbor these agents is important in providing the necessary protection for employees and students and their close contacts; animals; and the environment. Use, possession, storage or transfer of material defined in Part B requires approval from the Institutional Biosafety Committee (IBC) and the Office of Research and Economic Development (ORED) (see FSH 1640.14). In addition, federal or state approval may be required when conducting research activities using select agents and toxins (see APM 45.20), when releasing genetically modified organisms or biological agents to the environment, or when transferring biological agents to another researcher or facility.

All forms of work involving potential for occupational exposure to human blood, bodily fluids or other infectious materials are required to comply with the UI Bloodborne Pathogens Program, ensuring that hazards from potentially infectious materials are minimized by using safe work practices, annual training, engineering controls, personal protective equipment (PPE), and decontamination of spills.

B. Definitions.

B-1. Biological agents. Any biological material, including but not limited to bacteria, recombinant DNA, fungi, viruses, parasites and biological toxins, that can be harmful to humans, animals, plants or the environment or that have been genetically modified.

B-2. Plant or plant pest that requires federal or state permit. Materials whose movement is restricted by either national or state quarantine.

B-3. Bloodborne pathogens (BBP). Pathogens or other infectious materials transmitted through human bodily fluids, including but not limited to human immunodeficiency virus, hepatitis B, or hepatitis C.

C. Procedures. The IBC approves activities involving the materials defined in Part B and serves as a resource for providing information on biohazard safety and management of infectious materials.

C-1. Biosafety Protocol. Any investigator working with the material listed in Part B must complete a Biosafety Protocol.

a. Duration of Biosafety Protocol Approval; Renewal. An approved protocol is valid for a maximum of three years. If the investigator plans to continue work described in the protocol beyond the approval it is the responsibility of the investigator to obtain renewal prior to protocol expiration.

b. Amendment to Biosafety Protocol. Amendments must be submitted to and approved by the IBC prior to a change in protocol. Examples of changes requiring protocol amendment include additional biological agents or type of biohazardous material, updated scope of work, modifications of protocol or operating procedures, location of use, or updated personnel.

c. Required Documentation. A copy of the approved biosafety protocol, along with associated documentation on research protocols and training of lab personnel must be kept on file with the investigator.

C-2. Biosafety Manual and Facility Review. The investigator must complete a biosafety manual (BSM) or other IBC approved manual, depending on the biological agent (e.g. an exposure control plan for bloodborne pathogens or abbreviated BSM for samples containing unknown hazards), and facility review.

C-3. Exposure Control Plan (ECP). Those personnel with occupational exposure to BBP outside the scope of IBC oversight must complete an ECP and submit it to Environmental Health and Safety (EHS) for review and approval.

C-4. Shipping Biological Materials. Shipping of all biological materials must follow protocols set by EHS and ORED.

D. Additional Federal and State Compliance Obligations. Investigators may also be subject to compliance obligations imposed by federal and state agencies. Frequently arising federal and state obligations are briefly described below. Receipt of a grant or approval from a federal or state agency does not relieve the investigator from obtaining biosafety protocol approval prior to conducting work with any of the above materials in Part B.

D-1. National Institutes of Health (NIH). When the University receives funding from NIH for recombinant DNA activities, all research involving recombinant or synthetic nucleic acid activities is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules.

D-2. USDA Animal and Plant Health Inspection Service (APHIS) and Idaho State Department of Agriculture (ISDA). APHIS and ISDA require permits for the use, possession, storage, and transfer of plant materials.

D-3. Centers for Disease Control and Prevention (CDC) and USDA. CDC and USDA regulate the use, possession, storage, and transfer of select agents and toxins. An investigator must register to use select agents and toxins. To begin the registration process, contact the IBC.

D-4. Occupational Safety and Health Administration (OSHA) and Idaho General Health and Safety Standards (IGSHS). OSHA and IGSHS set employer requirements when employees may encounter occupational exposure to BBP or other potentially infectious materials. See the UI Bloodborne Pathogens Manual, which incorporates the requirements of 29 CFR 1910.1030 and IGSHS - 330

E. Contact Information.

For biosafety: Office of Research Assurances at 208-885-4054 or biosafety@uidaho.edu.

For bloodborne pathogens: Environmental Health and Safety at 208-885-6524 or safety@uidaho.edu.

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